Nasal packing device

ABSTRACT

A kit for packing and supporting the nasal cavities after surgical procedures performed on the nose comprising two inflatable non-elastomeric balloons ( 6′, 6″ ) and inflation means ( 27 ) arranged so that, in use, each balloon ( 6′, 6″ ) can be located in a nasal cavity and inflated.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.10/258,380, filed Oct. 23, 2002, which is the U.S. National Stage entryof International Application No. PCT/GB01/01998, filed May 4, 2001,which claims priority to United Kingdom Patent Application No. GB0011053.6, filed May 9, 2000, now abandoned, the complete disclosures ofwhich are incorporated herein by reference for all purposes.

BACKGROUND OF THE INVENTION

The present invention relates to apparatus and methods for packing nasalcavities. In particular, the present invention relates to a nasalhaemostatic device for packing and supporting the nasal cavities aftersurgical procedures performed on the nose.

In certain plastic surgical procedures, and in certain plastic surgery(rhinoplasty and septoplasty), it is necessary to cut and modify thenasal septum, that is, the cartilage-like material which separates theleft and right chambers of the nose.

There is a technical problem with known nasal packing materials becauseit is difficult to pack the nasal cavity in a manner that not onlyensures good healing but also equal healing on each side of the nasalseptum. Moreover, unless great skill is used by the physician, one sideof the septum may be packed more tightly than the other side thuscausing deformation of the healed septum. Such a deformity is typicallyregarded as unacceptable by the patient, particularly if the operationwas for cosmetic purposes, that is, plastic surgery.

Accordingly, there is a need for improved methods and apparatus forpacking nasal cavities.

SUMMARY OF THE PREFERRED EMBODIMENTS

According to a first aspect, the present invention provides a kit forpacking nasal cavities comprising two inflatable non-elastomericballoons and inflation means arranged so that, in use, each balloon canbe located in a nasal cavity and inflated.

In use, the balloons are inserted in the left and right chambers of thenose respectively and each balloon inflated. This allows the physicianto control the amount of pressure applied to each side of the septum toavoid any possible deformity to the nose.

According to a first embodiment, the inflation means comprises twoseparate inflation lines, each balloon is connectable to a separateinflation line and each balloon is connectable to a single inflationport by the two separate inflation lines. Preferably, the inflationlines are arranged so that, in use, each balloon is inflated to anidentical pressure. This ensures that exactly the same pressure isapplied to each side of the septum to avoid any possible deformity tothe nose. Moreover, as the method is not reliant on the skill andexpertise of a particular physician the apparatus will therefore be moreappealing for use by a range of users.

According to a second embodiment, the inflation means comprises a singlecommon inflation line and each balloon is connectable to a singleinflation port by the single common inflation line. Preferably, theinflation line is arranged so that, in use, each balloon is inflated toan identical pressure.

The haemostatic nasal packing device according to the second embodimentof the invention allows the user to pack both the anterior and posteriornasal chamber of a single nostril simultaneously following surgicalprocedures. Moreover, each of the two balloons may be inflated toidentical pressures thereby ensuring that exactly the same pressure isapplied to the anterior and posterior nasal chamber thus mitigating anypossible deformity to the nose.

Preferably, the kit of the present invention includes at least onepressure control means for automatically controlling inflation of theballoons so that each balloon is inflated to an identical predeterminedpressure.

According to a third embodiment, the inflation means comprises twoseparate inflation lines, each balloon is connectable to a separateinflation line and each inflation line includes at least one pressurecontrol means for automatically controlling inflation of the balloonconnected thereto so that the balloon is inflated to a predeterminedpressure.

The term “automatically controlling the inflation of the balloon so thatthe balloon is inflated to a predetermined pressure” means that theballoon is inflated to a preselected pressure level without the need formonitoring and/or control by a physician or other users of the device.

The automatic control means solves the technical problem of ensuringthat the pressure in the non-elastomeric balloons do not exceed aspecific preselected value. This reduces the risk of side effects suchas trauma and toxic shock syndrome. Moreover, as the method is notreliant on the skill and expertise of a particular physician theapparatus will therefore be more appealing for use by a range of users.The methods of the invention should result in improved patientcompliance compared to alternative surgical procedures.

Still further if separate pressure control means are used and both arepreset to different predetermined pressure values then the user mayapply different pressures to each side of the nasal septum to inducedesirable shape changes during healing.

Preferably, one or both of the balloons has a soft pliable wall madefrom a non-elastomeric polymeric material.

It is well known to a skilled person in the art that all plasticpolymers are elastic to some extent in the strict definition of theword, that is, they obey Hooke's Law and have the ability to return totheir original shape after being deformed. However, it is the extent towhich the polymers can be deformed which distinguishes non-elastomericpolymeric materials from elastomeric polymeric materials.

By the term “elastomeric polymeric material” we include the meaning of apolymeric material which at room temperature can be stretched to atleast twice its original length and upon immediate release of the stresswill quickly return to approximately its original length. Examples ofelastomeric polymeric materials include rubber and silicon rubber.

By the term “non-elastomeric polymeric material” we include polymericmaterials, such as nylon, which, although flexible, do not fall withinthe functional definition given above for elastomers.

Preferably, one or both of the balloons has a fixed volume which ensuresthat the pressure in the balloon is independent of the volume of theballoon. The fixed volume non-elastomeric polymeric balloon of thedevice of the invention ensures that adverse effects associated withwall elasticity of known elastomeric balloons are eliminated or at leastsubstantially mitigated, as all of or most of the pressure within theballoon is directly applied to the wall of the body cavity.

Preferably, the diameter, length and volume of each of the balloons isdesigned to be slightly greater than that of a nasal cavity likely to bepacked during a particular surgical procedure. More preferably, theballoon has a diameter of between 10 mm and 75 mm, a length of between 5mm and 100 mm and a volume of between 0.5 ml.sup.3 and 450 ml.sup.3.

Preferably, the pressure control means comprises an electrical pressuretransducer, well known to a person skilled in the art, which constantlymonitors the pressure in the balloons using an electronic instrument.Preferably, the arrangement is directly linked to an electricalinflation device which is programmed to increase the pressure in theballoons to the required predetermined value, and automatically hold itat that value.

Alternatively, the pressure monitoring means comprises a valve that isoperable to prevent further inflation of the balloons when the balloonsare inflated to the predetermined pressure. More preferably, the valveis a pressure relief valve which is pre-set at the required pressurevalue and will vent pressure medium when balloon pressure reaches itspre-set value. Most preferably, the valve comprises a tubular memberhaving an outlet in the side wall, a valve cover releasably sealing theoutlet and moveable between a sealing position and an open position, anda resilient biasing means, such as a spring, for biasing the valve covertowards the sealing position so that the valve cover moves to the openposition when the balloons are inflated above the predeterminedpressure. Since the inflation medium is usually air, venting of excesspressure to the atmosphere is most convenient.

Silicone rubber which is used in some elastomeric balloons is permeableto air. Such silicone balloons cannot be inflated with air if inflationis to be sustained. If sustained inflation must be maintained, asilicone balloon must be inflated with a liquid medium such as water ora saline solution.

If air is used as the inflation medium, then non-elastomeric balloonsused in the apparatus of the present invention must not be permeable toair. A suitable material is polyvinyl chloride (PVC), but other suitablematerials may be used.

Although the relationship between volume and pressure is not linear whenusing an elastic inflation medium such as air, because the pressurecontrol means is only dependent on the pressure within the balloons thisnon-linear behaviour of an elastic inflation medium does not affect theoperation of the apparatus of the present invention.

By increasing or decreasing the force of the resilient biasing means itis possible to adjust the desirable preset pressure value in theballoons in a quick and cost effective manner. Preferably, the resilientbiasing means comprises a spring load pin. The pressure value at whichthe valve cover will move to the open position thereby allowing theballoons to deflate is dependent on the tension of the spring and thecross-sectional area of the valve opening. Since the valve cover is onlyheld in place by the spring, the apparatus is practically fail safe.Such valves are well known to a person skilled in the art.

In use, a user may use a syringe or a bladder type hand pump which has alarger capacity than that required to inflate the balloon to thepredetermined pressure. The syringe is slowly operated to its maximumbut the pressure relief valve will vent when the predetermined pressurevalue is reached. Hence, the balloons are inflated to the requiredpressure in a simple operation, without any skill or independentpressure control by the user.

Conveniently, a restriction means is provided in the inflation linesdistal to the pressure relief valve so that inflation is not carried outtoo quickly, that is, faster than the venting capacity of the reliefvalve.

Alternatively, the pressure control means comprises a separate portablepressurised container that is charged with a pressurised inflationmedium, such as compressed air. The pressurised inflation medium ischarged to a specific value so that when it is connected to theinflation line, the inflatable balloons are charged to a predeterminedpressure. It will be apparent to a skilled person in the art that theremust be sufficient pressurised inflation medium in the container tocounterbalance the pressure drop that will occur by filling theballoons.

In a particular preferred arrangement the pressure control means isoperable to permit automatic controlled inflation of, the balloons to atleast two predetermined pressures. A particular advantage of such anarrangement is that this allows the balloons to be inflated to arelatively high initial pressure following insertion to attain immediatehaemostasis. After this effect has been achieved, typically after 20 to30 minutes, the pressure in the balloons can be reduced to mitigatepossible side-effects such as trauma due to prolonged residence of theballoons in the nasal cavities.

Most preferably, this type of dual pressure inflation arrangementcomprises two pressure relief valves, as mentioned hereinbefore, namelya first pressure relief valve that is operable to prevent furtherinflation of the balloon when the balloons are inflated to the initialpredetermined pressure (initially up to 25 KPa); and a second pressurerelief valve for reducing the pressure in the inflated balloons to alower predetermined pressure (between 4 to 12 KPa). This type ofarrangement further includes a switching means for independentlyswitching between each of the valves to permit the balloons to beautomatically inflated to different predetermined pressures.

Preferably, the switching means is a standard change over valve whichmay be located either on the input or exhaust side of the pressurerelief valves. In use, the change over valve should initially be set sothat the high pressure relief valve is in line with the balloons. Afterthe balloon has been inflated, for example with air, for approximately20 minutes the change over valve can be moved so that the low pressurerelief valve is in line with the balloon to allow the balloon to deflateto a lower predetermined pressure.

Alternatively, the dual pressure inflation arrangement may contain asingle pressure relief valve which is adapted to permit selectiveinflation/deflation of the balloons. For example, the tubular member ofthe pressure relief valve as mentioned hereinbefore may comprise twooutlets each of which are releasably sealed by a valve cover. Each valvecover may be biased towards the closed position for example by twoseparate spring load pin arrangements, as described hereinbefore. Eachof the spring loaded pins may have different tensions ie a differentspring rate, and/or each of the valve openings/valve covers may havedifferent cross-sectional areas, so that each cover opens at a differentpredetermined pressure. In this arrangement, the switching means permitsselective communication between the balloons, inflation means andindependently each outlet of the pressure relief valve.

In both of the dual pressure inflation arrangements including thepressure relief valves, the switching means may comprise removable valvecaps sealing the valve outlets. In use, the balloons can beinflated/deflated to the desired predetermined pressure by simplyalternately removing and replacing the valve caps.

The device including two separate inflation lines connected to a commoninflation port may have a separate pressure control means located ineach inflation line or a single common pressure control means located atthe proximal end of both inflation lines.

Preferably, the apparatus also includes a delivery means. Preferably,the delivery means for inserting the balloons into the nasal chambers isa catheter which includes the inflation line.

Preferably, the pressure control means is located in the inflation lineof the delivery means so that in, use the pressure control means remainsoutside the patient's body, thereby increasing patient compliance. Morepreferably, the inflation line includes a restriction distal to thepressure relief valve to ensure that the balloons are not inflated tooquickly, in particular so that the balloons are not inflated faster thanthe venting capacity of the relief valve. This provides the advantage ofproviding a further additional safety feature to ensure that theballoons are not over inflated.

Preferably, the apparatus includes a non-return valve such as a luerslip valve proximal to the restriction. Preferably, the luer slip valveis opened by the tip of the inflation device ie the syringe to allow theballoons to be inflated and the luer slip valve closes on removal of theinflation device to ensure that the inflated balloons do not deflatecompletely. It will be appreciated that the inflation device ie thesyringe could also be used to deflate an inflated balloon by withdrawingthe barrel of the syringe.

Alternatively, the luer slip valve may be operable to permit deflationof an inflated balloon.

Preferably, one or both of the balloons are releasably connected to thedelivery means and one or both of the balloons are associated with anagent that retards or prevents bleeding.

The term “an agent that retards or prevents bleeding” includes anyhaemostatic agent that is capable of arresting, stemming or preventingbleeding by means other than inducing tissue growth alone. In otherwords, it is not tissue growth alone which is responsible for retardingor preventing bleeding. It will of course be appreciated that thehaemostatic agent may have the beneficial property of inducing tissuegrowth in addition to its retardation or prevention of bleedingproperty.

Preferably, the haemostatic agent is a bioactive compound or compositionwhich causes vasoconstriction and/or blood coagulation.

Examples of preferred haemostatic agents that retard or prevent bleedinginclude oxidised cellulose, such as Tabotamp.™. sold by Johnson andJohnson, calcium alginate, gelatine or collagen. A particularlypreferred agent is carboxymethylated cellulose which can be purchasedfrom Courtaulds Special Fibres, PO Box 111, 101 Lockhurst Lane,Coventry, England, CV6 5RS. Combinations of different agents may be usedwithin the scope of the invention.

Preferably, the haemostatic agent that retards or prevents bleeding isprovided in the form of a net or knitted, especially a weft knitted,textile material that envelopes one or both of the balloons. Morepreferably, the net or knitted textile material is fixed to theballoon(s) and/or has a roughened surface to promote growth of fibroustissue around the outer surface of the balloon(s) thereby anchoring itto the interior wall of the body cavity.

Alternatively, the haemostatic agent that retards or prevents bleedingis provided in the form of a flexible film that coats the outer surfaceof the balloon(s). Preferably, the flexible film has a roughened surfaceto promote tissue growth.

However, it will be appreciated that if the haemostatic agent whichprevents or retards bleeding is either in itself or in conjunction withthe pressure exerted by the balloons relatively fast-acting, the ballooncan be fixed to the delivery means and can simply be pushed inside thenasal cavity until the bleeding has been prevented or retarded and thenremoved is after the repaired septum has healed.

The invention will be further described with reference to the followingnon-limiting examples and drawings wherein:

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view, partially cross sectioned, of a typical luer slipvalve;

FIG. 2 is a plan view of the end of the valve in FIG. 1 taken along theline A-A;

FIG. 3 is the luer slip valve of FIG. 1 incorporated into a safety cuffor pilot balloon;

FIG. 4 is a plan view of the pilot balloon and valve shown in FIG. 3taken along the line B-B;

FIG. 5 is the first embodiment of the invention with the dual inflatableballoons connected to a single inflation port by separate inflationlines;

FIG. 6 is another embodiment of the invention with the dual inflatableballoons connected to a single inflation port by a single commoninflation line;

FIG. 7 is the same as FIG. 6 except the balloons include a haemostaticnet;

FIG. 8 is a typical pressure relief valve;

FIG. 9 shows the combination luer slip valve, pressure relief valve, therestriction, the pilot balloon and inflation line; and

FIG. 10 shows two different pressure relief valves, and a sealing cap onthe most proximal, and lowest pressure valve.

DETAILED DESCRIPTION OF THE EMBODIMENTS

1. Standard Inflation Port

There is shown in FIGS. 3 and 4 a typical inflation port arrangement (1)used in a known balloon inflation device suitable for treating ableeding body cavity. The device (1) consists of a luer slip valve (2),a pilot balloon (3) or safety cuff (3) connectable to an inflation tube(4).

As shown in FIGS. 1 and 2 the luer slip valve (2) includes a port (5)that opens upon insertion of a tip of a syringe and automatically closeswhen the syringe is removed. Such an arrangement allows a balloon (notshown) to be inflated with an inflation medium and to remain inflatedupon removal of the syringe.

It will be appreciated by a person skilled in the art that a bladdertype hand pump fitted with a luer type inflation nozzle or a connectorwhich is fitted to a syringe may be used instead of a syringe.

2. Device With Separate Inflation Lines

There is shown in FIG. 5 a haemostatic nasal packing device comprising atypical inflation port arrangement (1) in combination with twoinflatable elastomeric balloons (6, 6′) each of which are in fluidcommunication with the pilot balloon (3) via separate inflation lines(4, 4′). Typically, the inflation lines are about 40-50 mm long.

Each of the balloons (6, 6′)include a haemostatic fabric shroud (7, 7′)secured to the distal tip of the respective balloon (6, 6′) by a fabricring clamp (8, 8′). Each balloon is releasably mounted to a deliverycatheter (9, 9′).

For packing the nasal cavities following a surgical procedure on thenose, the balloons (6, 6′) and haemostatic fabric shroud (7, 7′) areinserted into the left and right chambers of the nose respectively. Asyringe containing air is inserted into the inflation port (5) of theluer slip valve (2) and air introduced into the apparatus. Both balloonsare inflated to identical pressures i.e. between 4 to 25 Kpa.

This enables haemostasis to be achieved and ensures that exactly thesame pressure is applied to each side of the septum therefore mitigatingany possible deformity to the nose. After the septum has healed theballoons (6, 6′) are deflated by inserting a syringe into the inflationport (5) of the luer slip valve (2) and withdrawing the barrel of thesyringe. The balloons (6, 6′) are then removed from the nose.

3. Device With a Single Inflation Line

There is shown in FIGS. 6 and 7 a nasal packing device comprising atypical inflation port arrangement (1) in combination with twoinflatable elastomeric balloons (6, 6′) each of which are in fluidcommunication with the pilot balloon (3) via a single common inflationline (4). Typically, the inflation line is about 40-50 mm long.

The two separate balloons (6, 6′) are mounted on a common deliverycatheter (9) and as illustrated in FIG. 7 the two balloons (6,6′)include a haemostatic fabric shroud (7) secured to the distal tip of thedistal balloon (6) by a fabric ring clamp (8).

Following a surgical procedure on the nose, the balloons (6, 6′) areinserted into a single nasal cavity. The balloons of a complimentarydevice may also be inserted in the other nasal cavity. Inflation anddeflation of the balloons may be achieved by following the proceduredescribed hereinbefore (see Section 2 above).

The nasal packing device not only ensures that both balloons (6, 6′) areinflated to identical pressures but allows the user to pack both theanterior and posterior nasal chambers of a single nostrilsimultaneously.

4. Pressure Relief Valve

A typical pressure relief valve (10) is shown in FIG. 8. The pressurerelief valve comprises a spring (25) which biases a sealing gasket (11)in towards a closed position against the pressure generated by theinflation medium in the main chamber (13). When the pressure in the mainchamber (13) exerts a force on the sealing gasket (11) which exceeds theforce exerted by the spring (25) biasing the sealing gasket (11) towardslo the closed position, the sealing gasket moves to an open positionwhich allows the inflation medium to vent through the release vent (15).When the pressure of the inflation medium in the chamber (13) equals theforce of the spring (25) exerted on the sealing gasket (11), the sealinggasket (11) will move from the open to the closed position. Thus thepressure relief valve allows a maximum predetermined pressure to bemaintained in the chamber (13). The maximum predetermined pressure maybe varied by changing the force exerted by the spring (25) on thesealing gasket (11) and/or by increasing/decreasing the cross-sectionalarea of the vent/sealing gasket (11).

Preferably, the release vent (15) is in the form of a female luerfitting so that the exit (17) make be sealed with a male luer plug (19).

5. Single Pressure Relief Valve

There is shown in FIG. 9 a preferred embodiment of an inflation portarrangement (21) for use with the apparatus of the present inventioncomprising a luer slip valve (2), a pressure relief valve (10), apilot-balloon (3), an inflation line(s) (4) and a restriction (23)distal of the pressure relief valve (10). It will be appreciated thatall parts of the inflation port arrangement (21) are in fluidcommunication with each other and the distal end of the inflation,line(s) (4) is connectable to the non-elastomeric inflatable balloons.

The luer slip valve (2) allows air or another inflation medium to beintroduced into the inflation tube (4) via a syringe, thereby inflatingthe non-elastomeric balloons. The pressure relief valve (10) will allowthe inflation medium to vent from the system at a predetermined pressureas described hereinbefore. Hence, this inflation port arrangement (21)allows a user to inflate the balloons to a maximum pre-set pressure andto maintain the inflated balloon at that pressure (i.e. up to 25 KPa).

The restriction (23) ensures that the pressure of the inflation mediumie air in the inflation tube(s) (4) does not rise above thepredetermined maximum value as it prevents the inflation medium frombeing forced into the inflation tube (4) faster than the rate at whichthe vent (15) can vent excess pressure in the chamber (13).

6. Dual Pressure Relief Valve

There is shown in FIG. 10 an alternative preferred embodiment of aninflation port arrangement (27) for use with the apparatus of thepresent invention comprising two pressure relief valves (10′, 10″), aluer slip valve (2), a pilot balloon (3), an inflation line(s) (4) and arestriction (23) distal of the pressure relief valves (10′, 10″).

In FIG. 10 and FIG. 11, the parts described herein before are indicatedby the same reference numerals.

The two pressure relief valves (10′, 10″) comprise a pressure reliefvalve (10′) which is adapted to vent at a lower predetermined pressurethan the other pressure relief valve (10″). As mentioned above, this maybe achieved by using springs (25′, 25″) having different tensions andsealing gaskets (11′, 11″) having different cross-sectional areas. Thisarrangement allows the inflatable balloons (6, 6′) to be inflated to twodifferent predetermined pressures.

FIG. 11 illustrates the inflation port arrangement (27) in combinationwith two inflatable non-elastomeric balloons (6′, 6″) mounted onseparate delivery catheters (9, 9′) which are in fluid communicationwith the inflation lines (4, 4′).

As described hereinbefore, the balloons (6, 6′) include a haemostaticfabric shroud (7, 7′) secured to the distal tip of the balloons (6, 6′)by a fabric ring clamp (8, 8′).

Following a surgical procedure, the balloons are inserted into therespective left and right chambers of the nose. The vent (15′) of thelow pressure relief valve (10′) is initially capped with a male luer cap(19) to prevent the inflation medium ie air from venting through thisvalve (10′). The second higher pressure relief valve (10″) initially hasits vent (15″) open.

A syringe containing air is inserted into the inflation port (5) of theluer slip valve (2) and air introduced into the apparatus. The balloons(6, 6′) inflate to the higher preset pressure limit, ie between 12 to 25KPa, as determined by the higher pressure relief valve (10″) and remaininflated at this pressure. This high pressure relief valve (10″) may beconfigured so that the pressure in the balloons is slightly higher thannormal blood pressure. This enables rapid haemostasis to be attained.

After an initial haemostasis has been achieved the balloon may bedeflated to the lower preset pressure, ie between 4 to 12 KPa, byremoving the male luer cap (19) from the vent (15′) of the low pressurerelief valve (10′). This allows the healing nasal cavity to stabilise,it is more comfortable for the patient, and it is less likely to causemedical complications ie deformation of the nasal cavity.

It will be appreciated by a person skilled in the art that although theillustrations in this description have referred to standard luerfittings any suitable seals, fasteners, vents, vent caps and connectorsmay be used.

Furthermore, any number of pressure relief valves could be used to allowthe balloons to be inflated to a number of different pre-set pressurevalues. Each preset pressure value could be chosen by selectivelyclosing the vents of the pressure relief valves by luer lock caps orsome other form of sealing connector.

Alternatively, a valve having a vent sealed with a plug but without aspring loaded seal may be included in the apparatus of the presentinvention. Removal of the plug from this type of valve will prevent theballoons from being inflated, and if the balloons are already inflated,will cause them to deflate. This type of valve will allow the balloonsto be deflated in an emergency situation even if a syringe is notreadily to hand.

It is important to match the pressure controlled inflation system with anon-elastomeric, fixed volume balloons. Provided the volume of theballoons are bigger than the nasal chambers which are being treated thenthe pressure in the system is the same as the pressure applied to thenasal chambers. This is in contrast to using a balloon made from anelastomeric material where some of the pressure in the balloon isutilised in overcoming the forces within the balloon material itself.Consequently, with an elastomeric balloon there is no direct control ofthe actual force applied to the bleeding cavity.

The devices incorporated in this invention are typically low pressuredevices and will work at pressures up to approximately 25 KPa (Kilopascals). A typical dual pressure device may have the high pressure setbetween 12 and 25 KPa and the low pressure set between 4 and 12 KPa.However, the principles of the invention should not be restricted tosuch low pressure devices.

1. A kit for packing nasal cavities comprising: two inflatablenon-elastomeric balloons; an inflation line, each balloon connectable tothe inflation line; and wherein the two balloons are mounted on a commondelivery catheter and are positioned so that one of the balloons may bepositioned in an anterior portion of a single nostril and the other ofthe balloons may be positioned in a posterior portion of the singlenostril, wherein one or both of the inflatable balloons are associatedwith an agent that retards or prevents bleeding within the nasal cavity,the agent provided in the form of a shroud secured to one or both of theballoons.
 2. A kit as claimed in claim 1 wherein the inflation linecomprises two separate inflation lines, each balloon is connectable to aseparate inflation line and each balloon is connectable to a singleinflation port by the two separate inflation lines.
 3. A kit as claimedin claim 1 wherein one or both of the balloons has a fixed volume.
 4. Akit as claimed in claim 1 wherein one or both of the balloons areconstructed from a non-elastomer polymeric material.
 5. A kit as claimedin claim 4 wherein the non-elastomer polymeric material is PVC.
 6. A kitas claimed in claim 1 further including a non-return valve to preventdeflation of the balloons.
 7. A kit as claimed in claim 6 wherein thenon-return valve is a luer slip valve.
 8. A kit as claimed in claim 1wherein the agent that retards or prevents bleeding is selected from oneor more of oxidised cellulose, carboxymethylated cellulose, calciumalginate, gelatine or collagen.
 9. A kit as claimed in claim 1 whereinthe shroud is provided in the form of a net or a knitted textilematerial that envelopes one or both of the inflatable balloons or in theform of a flexible film that coats the outer surface of one or both ofthe balloons.
 10. A kit as claimed in claim 9 wherein the net or knittedtextile material is fixed to one or both of the balloons by a fabricring clamp.
 11. A kit as claimed in claim 1 wherein one or both of theballoons are not permeable to air.
 12. A kit as claimed in claim 1further comprising a pressure control means, wherein the apparatus isadapted to permit the pressure control means to remain external to thebody of a patient.
 13. A kit as claimed in claim 1 wherein each balloonis in fluid communication with a single pilot balloon by the inflationline.
 14. A kit for packing nasal cavities comprising: two inflatablenon-elastomeric balloons; two separate inflation lines, each balloonconnectable to a separate inflation line; wherein each balloon is influid communication with a single pilot balloon by the two separateinflation lines; and wherein the two balloons are mounted on a commondelivery catheter and are positioned so that one of the balloons may bepositioned in an anterior portion of a single nostril and the other ofthe balloons may be positioned in a posterior portion of the singlenostril, wherein one or both of the inflatable balloons are associatedwith an agent that retards or prevents bleeding within the nasal cavity,the agent provided in the form of a shroud secured to one or both of theballoons.
 15. A kit as claimed in claim 14 wherein one or both of theballoons has a fixed volume.
 16. A kit as claimed in claim 14 whereinone or both of the balloons are constructed from a non-elastomerpolymeric material.
 17. A kit as claimed in claim 14 wherein the agentthat retards or prevents bleeding is selected from one or more ofoxidised cellulose, carboxymethylated cellulose, calcium alginate,gelatine or collagen.
 18. A kit as claimed in claim 14 wherein theshroud is provided in the form of a net or a knitted textile materialthat envelopes one or both of the inflatable balloons or in the form ofa flexible film that coats the outer surface of one or both of theballoons.
 19. A kit as claimed in claim 18 wherein the net or knittedtextile material is fixed to one or both of the balloons by a fabricring clamp.
 20. A method of treating a nasal cavity comprising:inserting two inflatable non-elastomeric balloons into a single nostril,wherein the two balloons are mounted on a common delivery catheter;inflating one of the two balloons positioned in the posterior portion ofthe nostril to pack the posterior nasal chamber of the nostril; andinflating the second of the two balloons positioned in the anteriorportion of the nostril to pack the anterior nasal chamber of thenostril.